Kornimate/medical-research-clean huggingface dataset:
patient-centered outcomes during using self-ligating brackets with or without piezocision vs traditional brackets

Conditions: Crowding, Tooth

Summary: the different types of brackets (e.g., self-ligating and conventional brackets), and the various acceleration methods (e.g., corticotomy) cause varying degrees of pain and discomfort. this study will assess pain, discomfort, and other patient-centered outcomes in adults with severe crowding on the upper jaw requiring two first premolars extraction. there are three groups: the first group (control group): the patients in this group will be treated using conventional brackets alone. the second group (experimental group): the patients in this group will be treated using self-ligating brackets alone. the third group (experimental group): the patients in this group will be treated using self-ligating brackets associated with flapless corticotomy.

pain associated with orthodontic treatment is one of the undesirable complications, which negatively affects the patient's cooperation. pain may occur due to the pressure on the periodontal ligaments induced by orthodontic forces. the perception of pain is affected by many factors related to the patient, such as age, gender and any previous treatment experiences, which are negatively or positively reflected on the patient's cooperation. as for the factors related to the type of orthodontic treatment provided, the pain and discomfort are proportional to the brackets system used and the forces applied, especially in the leveling and alignment stage. the amount of tooth movement is directly affected by the friction between the brackets and the wires used. the physical properties of the wire and brackets used and the dimensions of the applied wires, in addition to the type of ligation play a significant role in the amount of friction generated.

Eligibility criteria:
inclusion criteria: 1. the patient's age is between 18 and 25 years 2. severe crowding on the upper jaw (more than 6 mm) requires upper first premolars extraction 3. little's index of irregularity is greater than 7 mm 4. overbite ranging between 0-4 mm 5. normal inclination of the upper incisors 6. no missing teeth (except for third molars) 7. class i or class ii (anb ≤ 5) or class iii (anb ≥ 0) exclusion criteria: 1. the presence of any systemic disease affecting orthodontic movement 2. the presence of congenital syndromes or cleft lip and palate 3. poor oral health with a plaque index greater than (1) 4. skeletal maxillary constriction

Keywords: self-ligating brackets flapless corticotomy severe crowding leveling aligning
telephone counseling or standard care in patients who have completed treatment for stages i, ii, or iii cervical cancer

Conditions: Cervical Cancer; Psychosocial Effects of Cancer and Its Treatment

Summary: rationale: telephone counseling after treatment may reduce stress and improve the well-being and quality of life of patients who have cervical cancer. changes in quality of life may be related to changes in immune function and neuroendocrine function. purpose: this randomized phase i trial is studying how well telephone counseling works compared to standard care in reducing stress in patients who have completed treatment for stage i, stage ii, or stage iii cervical cancer.

objectives: * compare quality of life (qol) at baseline and changes in qol, immune response, and neuroendocrine parameters over time in patients who have completed treatment for stage i-iii cervical cancer receiving psychosocial telephone counseling vs usual care. * correlate psychosocial measures with immunologic stance. outline: this is a randomized, controlled, parallel-group study. patients are randomized to 1 of 2 intervention arms. * arm i: patients undergo psychosocial telephone counseling comprising 5 weekly sessions and a 1-month follow-up session to learn strategies for reducing stress. * arm ii: patients undergo usual care for approximately 4 months. all patients complete questionnaires and quality of life assessment at baseline and at 4 months. they also undergo saliva and blood sample collections at baseline and at 4 months for neuroimmune studies. projected accrual: a total of 50 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria disease characteristics: * diagnosis of cervical cancer between the past 3-15 months * stage i-iii disease * completed therapy for cervical cancer ≥ 1 month ago * not receiving ongoing treatment * more than 4 weeks since prior immunotherapy * more than 30 days since prior investigational drugs * no prior biological response modifier * no concurrent corticosteroids * no concurrent immunosuppressive therapy patient characteristics: * resident of orange, san diego, or imperial county in california * english or spanish speaking * no serious acute or chronic illness * has access to a telephone exclusion criteria disease characteristics: * stage iv cervical carcinoma * have undergone previous treatment with a biological response modifier (inferferons, interleukins) or prior immunotherapy within four weeks of study enrollment * used investigational drugs within 30 days of execution of the informed consent * required corticosteroids or were under immune suppression for any reason including an organ allograft or hiv infection * patients with metastatic disease or ongoing treatment * any acute or chronic illness, including autoimmune states, as judged clinically significant by the investigators patient characteristics: * non-english or spanish speakers

Keywords: psychosocial effects of cancer and its treatment stage ia cervical cancer stage ib cervical cancer stage iia cervical cancer stage iib cervical cancer stage iii cervical cancer
immunogenicity of novel h1n1 vaccination among hiv-infected compared to hiv-uninfected persons

Conditions: Influenza; HIV Infections

Summary: the purpose of this research is to determine the effectiveness of the novel h1nl influenza (inactivated/killed formulation) vaccine among both hiv-infected and hiv-uninfected persons. the administration of the h1nl vaccination is not part of the study's procedures, but is being given as part of routine care.

the investigators study is being conducted to evaluate and compare the seroresponses of the novel h1n1 vaccination among hiv positive and negative persons receiving the novel h1n1 vaccination as part of routine clinical care, with secondary objectives examining the impact of prior seasonal vaccinations on subsequent seroresponse to the novel h1n1 vaccination, determining potential reactions (local or systemic) to this new vaccine among patients, and assessing for potential immunologic/virologic changes (in cd4/hiv rna levels) after h1n1 vaccination among hiv patients. finally, the investigators will collect data on influenza-like illnesses (ili) and h1n1 events during the study follow-up period and influenza isolates causing ili events will be genetically characterized.

Eligibility criteria:
inclusion criteria: * 18-50 years of age * receiving the novel h1n1 vaccine (killed formulation) as part of routine clinical care * a military beneficiary who expects to remain in the local area for the next 6 months exclusion criteria: * healthcare worker who is involved in direct patient care * acute febrile illnesses within 30 days prior to h1n1 vaccination (e.g., pneumonia, influenza, ili) * diabetes type 1 or type 2 * systemic steroid or immunosuppressive medication use within 4 weeks of vaccination * active diagnoses of a cancer (non-melanoma skin cancer allowed). * history of organ transplant * chronic active hepatitis b or c * active illicit drug use or alcohol abuse * blood transfusion within the last year * allergy to eggs * previous significant adverse reaction (e.g., anaphylaxis) to the seasonal influenza vaccination * history of serious reactions to any prior vaccination (e.g., guillain barre syndrome (gbs)). * received another vaccination in the last 4 weeks (receipt of seasonal influenza vaccination is allowed) * among females of childbearing potential, pregnant or within 6 weeks of being postpartum * history of ili which was confirmed as an h1n1 infection

Keywords: hiv h1n1 influenza vaccination seroresponse immunogenicity vaccine
a repeat dose study with gsk1018921 to assess safety, tolerability, pharmacokinetics, pharmacodynamics in healthy volunteers and patients with schizophrenia and to evaluate its effect on pk of midazolam.

Conditions: Schizophrenia

Summary: the purpose of this study is to understand safety and tolerability of the drug gsk1018921 after 14 days of dosing in healthy volunteers and then in patient volunteers.

this is a four part, parallel group, randomised, study to evaluate the safety, tolerability, pharmacokinetics (pk) and pharmacodynamic (pd) effects of repeat doses of gsk1018921 in healthy volunteers and stable patients with schizophrenia and to evaluate its effect on pharmacokinetics of midazolam. part a will evaluate 14 days repeat bid dosing in at least three cohorts of healthy volunteers, to assess safety, tolerability, pharmacokinetics (pk) and pharmacodynamics (pd) of gsk1018921. part b will study the potential drug interaction of gsk1018921 (maximum tolerated dose from part a) with midazolam with 14 days repeat bid dosing in healthy volunteers and therefore will assess the pk, safety and tolerability. part c will be a single dose study in healthy volunteers and will include csf sampling to assess the concentration of gsk1018921 and glycine in csf with two doses (80 and 200 mg). part d will study stable patients with schizophrenia, to assess safety, tolerability, pk and pd following 28 days of repeat bid dosing. safety assessments will include physical examination, 12-lead ecgs, holter monitoring, vital signs, orthostatic vital signs, visual assessments, and clinical lab test. tolerability will be assessed by collecting adverse events. pd assessments will include glycine in red blood cells, plasma and csf, as well as cogstate battery test, visual assessment scale, positive and negative symptom scores (panss) and clinical global impression scales of change.

Eligibility criteria:
all subjects (healthy and patients) exclusion criteria: * history of drug or alcohol abuse. * consumption of drug, food or drink affecting the cyp450 metabolism pathway. * has received investigational drug within 30 days to 5 half lives or twice the duration of the biological effect of any drug (which ever is the longer). * donation of blood in excess of 500ml within a 56 day period. patients eligibility - stable patients with schizophrenia.

Keywords: schizophrenia gsk1018921 glyt-1 inhibitor healthy volunteers csf patient midazolam
the effect of a computer-assisted rehabilitation program on epilepsy patient

Conditions: Epilepsy; Computer-assisted Cognitive Rehabilitation; Quality of Life

Summary: the aim of this study is to examine the effects of the rehacom computer-assisted rehabilitation program applied to epilepsy patients on self-management, cognitive function and quality of life.

modules designed to train cognitive abilities will be used under the supervision of a licensed researcher who is licensed to use the rehacom application, which is a computer-assisted cognitive rehabilitation program. researchers can select some modules based on each patient's specific deficits, meaning that deficits can be targeted and specifically trained. since the program will respond to the patient's specific needs, the activity may become easier or more difficult depending on the patient's performance. epilepsy patients will be encouraged by researchers during the exercises and will be able to give feedback on progress at the end of the session. after determining the appropriate time and day for each patient in the experimental group, the intervention will continue for 6 weeks with 45-minute sessions once a week.

Eligibility criteria:
inclusion criteria: * being registered at selçuk university faculty of medicine hospital neurology polyclinic * having been diagnosed with epilepsy for at least 6 months * being between the ages of 18 and 60 (60 is the age limit for the moxo test) * volunteer to provide transportation to selçuk university faculty of medicine for research one day a week. * ability to use tools such as computer mouse and telephone * score 24 or more from the mini mental state test exclusion criteria: * individuals have physical, mental, visual and hearing disabilities * having another neurological disorder * the individual has a transportation disability

Keywords: epilepsy patient cognitive rehabilitation self management
berberine and polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome; Berberine

Summary: polycystic ovary syndrome (pcos) is the most frequent endocrine disease in female reproductive-age. recently, increasing evidence has shown that natural plant-based products may play a role in pcos management. previous study in pcos preclinical model and in humans demonstrated that berberine is an effective insulin sensitizer and improves homeostasis of metabolic, inflammatory and hormonal disorders. however, to date there is no clinical study that considers globally all the activities carried out by berberine in pcos clinical features. given this background, aim of this study was to evaluate in normal-overweight pcos women with normal menses the berberine effectiveness on: insulin resistance by homeostasis model assessment (homa); inflammation by c-reactive protein (crp), tnf-alpha; lipid metabolism; sex hormone profile and symptoms correlated to hyperandrogenism, such as acne, by global acne grading system (gags) and cardiff acne disability index (cadi); body composition by dual-energy x-ray absorptiometry. all these parameters were collected at baseline and 60 days after supplementation with a new bioavailable and safe berberine formulation. finally, adverse effects were assessed by liver and kidney functions. to evaluate statistically significant pre- post-supplementation changes, fitted a linear mixed model for each investigated endpoint was performed.


Eligibility criteria:
inclusion criteria: * normal and overweight women (body mass index (bmi) 25-30 kg/m2) * newly detected polycystic ovary syndrome exclusion criteria: * any concomitant medication * presence of liver, renal and thyroid disease * smoking * drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)

Keywords: berberine polycystic ovary syndrome
vitamin d deficiency and body composition in the patients with hemophilia

Conditions: Vitamin D Deficiency; Sarcopenia; Osteoporosis; Body Composition; Hemophilic Arthropathy; Hemophilia

Summary: hemophilia is associated with osteoporosis and increased prevalence of low bone mineral density (bmd). many clinical risk factors have been reported, such as hemophilic arthropathy, reduced physical activity, decreased sun exposure, hepatitis c virus infections, vitamin d deficiency, and low body mass index (bmi). there is no data on the prevalence of vitamin d deficiency and low bmd in hemophilia patients in taiwan or asia. to the best of our knowledge, no previous studies have reported the prevalence of sarcopenia and correlation with osteoporosis in hemophilia adult patients. the purpose of this study will evaluate the prevalence of vitamin d deficiency, low bmd, sarcopenia and body composition in a cohort of patients with hemophilia in taiwan.

hemophilia is associated with osteoporosis and increased prevalence of low bone mineral density (bmd). soucek et al. reported sarcopenia and low trabecular bmd at the radius in the boys with hemophilia by ct.the severity of hemophilic arthropathy associated with lower bmd, muscle atrophy and obesity has been shown by some studies. this is a single-center, cross-sectional, observational study. all participants will sign informed consent that fully disclosed the risks and benefits of study participation. the study will be performed at the hemophilia care and research center. sixty adult patients (age ≥ 20) with hemophilia and 20 healthy subjects will be enrolled for scanning of the lean tissue, appendicular skeletal muscle mass (asm), fat mass, lumbar spine and hip bmd by dual-energy x-ray absorptiometry (dxa) and assess serum vitamin d level. we will collect other clinically relevant information, including age, body mass index (bmi), hemophilia type and severity, inhibitor titer, pettersson score by x-ray, hjhs, handgrip strength, history of hcv or hiv infection and history of fracture.

Eligibility criteria:
inclusion criteria: * hemophilia patients exclusion criteria: * severe diseases affecting bone metabolism (such as primary hyperparathyroidism, hypogonadism), * history of total hip arthroplasty * history of instrumentation in lumbar spine
study of the safety, immunogenicity and lot comparability of daptacel when administered with other recommended vaccine

Conditions: Diphtheria; Tetanus; Whooping Cough; Polio; Haemophilus Influenzae Type b

Summary: this study was designed to assess the lot comparability of daptacel, as well as the safety and immunogenicity of daptacel when co-administered with other recommended infant vaccines. stage i primary objectives: 1. to assess the lot-comparability of immunogenicity of daptacel by when co-administered with other recommended vaccines. 2. to compare the immune response to dtap-ipv/hib (pentacel) with those of three lots of daptacel when co-administered with other recommended vaccines. 3. to compare the immune response of prp-t antigen in pentacel with that of acthib concurrently administered in a different injection site with daptacel when these vaccines are co-administered with other recommended vaccines. stage ii primary objectives: 1. to compare the immune response of daptacel when the 4th dose is co-administered with hib or other infant vaccines. 2. to compare the the immune response of pentacel with those elicited by daptacel when co-administered with acthib in toddlers.

this is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of daptacel

Eligibility criteria:
inclusion criteria : * healthy infants 2 months of age. * infants with at least 37 weeks of gestation at delivery. * signed informed consent from parent or guardian. * able to attend the scheduled visits and to comply with the study procedure. * subjects must have received the first dose of hepatitis b vaccine from birth to 28 days prior to the first dose of daptacel or pentacel. exclusion criteria : * clinically significant findings on review of systems or physical examination (determined by investigator or sub-investigator to be sufficient for exclusion). * known or suspected hypersensitivity to any component of the study vaccine to be administered. * known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth. * known hiv-positive mother. * personal or immediate family history of congenital immune deficiency. * developmental delay or neurologic disorders. * chronic medical, congenital, developmental or surgical disease. * participation in any other experimental vaccine trial. * any condition which, in the opinion of the investigator or sub-investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject. * prior history of having received more than one dose of hepatitis b vaccine, any diphtheria, tetanus and acellular pertussis combination vaccine (dtap), diphtheria, tetanus and whole-cell pertussis combination vaccine (dtwp), haemophilus influenzae type b (hib)-conjugate vaccine, poliovirus vaccine or pneumococcal conjugate vaccine

Keywords: daptacel diphtheria tetanus whooping cough polio haemophilus influenzae type b pertussis
crystalline glucosamine sulfate therapy in hand osteoarthritis

Conditions: Hand Osteoarthritis

Summary: the objective of this study is to retrospectively evaluate the symptomatic effects of crystalline glucosamine sulfate (gs), prescribed for the actually approved indication of knee oa, in addition to conventional therapy, in comparison to the conventional therapy alone in patients with primary hand osteoarthritis (hoa).this is a 6-months retrospective comparative study including patients with concomitant knee and primary hoa, according to the acr criteria. to be eligible the patients had to present clinical symptoms of hand oa for at least 3 months, defined as global hand pain score superior to 40 mm on a 0-100 visual analogue scale (vas) and a functional index for hand osteoarthritis (fihoa) score of at least 6. furthermore, the patients have had a radiographic evidence of hoa within the previous 6 months with a kellgren-lawrence score of ii-iii. the participants are stratified into two groups based on whether or not crystalline gs at the daily dose of 1500 mg was added to the conventional therapy for hoa, including exercise, acetaminophen and non steroidal anti-inflammatory drugs (nsaids) or cyclo-oxygenase (cox)-2 inhibitors. primary outcome measures are the difference between the two groups in the change of vas pain and in the fihoa, from baseline after 6 months. secondary outcomes were health assessment questionnaire (haq), medical outcomes study 36-item short form (sf-36) and symptomatic drugs consumption.


Eligibility criteria:
inclusion criteria: * mono or bilateral primary hoa and concomitant knee oa, according to the american college of rheumatology (acr) criteria * treatment for at least 6 consecutive months with crystalline gs at the daily dose of 1500 mg in addition to the conventional therapy or with usual care alone. * hoa symptoms duration for at least 3 months defined as global hand pain score superior to 40 mm on a 0-100 vas and a fihoa score of at least 6. * radiographic evidence of hoa within the previous 6 months with a radiological score of ii-iii (using the kellgren method). exclusion criteria: * erosive osteoarthritis of the hand * medical history of any inflammatory joint disease, septic arthritis, previous articular fracture of the concerned joints, monarticular post-traumatic oa of the finger, a history or the presence of any other rheumatic diseases that could cause secondary oa, such as hemochromatosis. * ongoing therapy with opioid analgesics and any kind of topical treatment * therapy with sysadoas other than gs, steroids by any route of administration and intra-articular injection of any joint with hyaluronic acid during the previous 6 months. * contraindications or special warnings for gs presented in the data sheet.